Package Insert and Label Information: Aplicare Povidone-Iodine Sponge

By Aplicare, Inc. | Last revised: 31 December 2009

APLICARE POVIDONE-IODINE SPONGE — povidone-iodine solution
Aplicare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Povidone Iodine Sponge Sticks

(click image for full-size original)

Povidone-iodine 10%

Antiseptic

Warnings

Do not use

if allergic to iodine
in the eyes

For external use only

Ask a doctor before use if injuries are

deep or puncture wounds
serious burns

Stop use and ask a doctor if

redness, irritation, swelling or pain persists or increases
infection occurs

Avoid pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Keep out of reach of children.In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

APLICARE POVIDONE-IODINE SPONGE
povidone-iodine sponge solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-0101
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (IODINE)	POVIDONE-IODINE	9.8 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
SODIUM HYDROXIDE
NONOXYNOL-9
WATER

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:52380-0101-5	90 g in 1 PACKET	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	03/01/1992

Labeler — Aplicare, Inc. (107255002)

Establishment
Name	Address	ID/FEI	Operations
Aplicare, Inc.		107255002	manufacture

Revised: 12/2009 Aplicare, Inc.